ABSTRACT
At the center of the developing global regulatory climate stand institutional review boards (IRBs) and ethics committees and the review systems they use. Both are independent groups, composed of both medical and nonmedical personnel, which ensure the protection, safety and well-being of clinical trial participants. They also review and approve study protocols, and evaluate the suitability of investigators, facilities and methods, as well as any material used to obtain and document informed consent. With different ethics committees often monitoring the same trial, it’s quite a task to comply with every policy.
